Surgical package and method for indicating sterilization thereof.



c. T. DAVIS. SURGICAL PACKAGE AND METHOD FOR INDICATING STERILIZATION THEREOF.

APPLICATION F |LED MAY 24 I916.

Patented July 18, 1916.

I 5 nvemfoz 351 M v awe wigs CHARLES T. DAVIS, 0F BROOKLYN, NEW YORK.

SURGICAL PACKAGE AND METHOD FOR INDICATING STERILIZATION THEREOF.

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Specification of Letters Patent.

Application filed May 24, 1916. Serial No. 99,536.

T 0 all whom it may concern:

Be it known that I, CHARLES T. DAVIS, a citizen of the United States, residing at Brooklyn, in the county of Kings and State of New York, have invented new and useful Improvements in Surgical Packages and Methods for Indicating Sterilization Thereof, of which the following is a specification.

' This invention relates to a surgicalpackage and method of indicating the sterilization of certain of the contents thereof, and has particular application to a package embracing a tube containing a storing or preserving fiuid in which is immersed or placed a surgical suture orligature and a fusible body, the latter being employed for the purpose of indicating when the suture or ligature has been subjected to adequate heat sterilization.

In the present instance, by way of illustration, I have shown and described my invention as applicable to a surgical package which consists of an inclosed hermetically sealed glass tube containing. a storing of preserving fluid, such for instance as toluol,

and in this fluid is placed a strand, suture or ligature of catgut, or other suitable material. In preparing such a package for use by the, surgeon, it is the practice to subject the sealed glass tube containing the fluid and the suture or ligature to the action of heat at a predetermined degree, in order that the suture or ligature may be thoroughly sterilized so that when implanted in the body of the patient, it will have no deleterious action. Should such ligature or suture be not properly sterilized, it is liable, after being implanted during a surgical operation, to produce more or less suppuration, and in some cases, to set up a deadly and fatal infection.

Now as a package of unsterilized sutures of this class has the same general appearance as a sterilized package of sutures, there is,

so far as I am aware, no method or means by which the surgeon or other person can tell whether or not the package of sutures intended to be used has been properlysteri lized, because, the process of heat sterilization, as above indicated, in no manner changes the appearance of the suture material or of the storing or preserving fluid forming the bath for the same. Thus, if through either accident, inadvertence, or for any other reason, a person in the laboratory should place or mix non-sterilized tubes or packages of this kind with those which have been sterilized, the non-sterilized packages might be sent out for use, as sterilized, with the resulting danger in their use, as above pointed out.

One of the objects of my invention is to obviate the liability and possibility of unsterilized packages of sutures being mistaken for properly sterilized packages, and to this end I have devised the surgical package forming the subject matter of the present invention and the novel method for positively, unmistakably and accurately indicating whether the package is sterilized or non-sterilized.

Another object of the invention is the provision of a package of this class having a fusible body forming a content of the tube so long as the latter remains sealed or unbroken, such fusible body constituting a permanent indication of the condition of the package so far as concerns sterilization or non-sterilization.

With the above recited objects and others of a similar nature in view, the invention consists in the package and the method of indicating the sterilization or non-sterilization thereof set forth in and falling within the scope of the appended claims.

In the accompanying drawings, Figure l is a view of my improved surgical package as it appears prior to sterilization. Fig. 2 is a detail view ofrone form of the fusible body as it appears in the package prior to the sterilization of the latter. Fig. 3 is a view in elevation of the surgical package as it appears after it has been properly sterilized. Fig. 4 is a detail view illustrating conventionally the fusible body as it appears melted into the form of a slug after the sterihzation of the package. Fig. 5 is a detail View, in elevation, of one member of a modified form of fusible device. Fig. 6 is a similar view of the other member of such modified form of device. -Fig. 7 is a View melevation showing the member illustrated Patented July as, rare. I

in Figs. 5 and 6, as assembled. Fig. 8 is a view of another modified form of fusible member. Fig. 9 is a perspective view of still another modified form of fusible member.

Referring now to the accompanying drawing in detail, and particularly to Figs. 1 to 4, inclusive, the letter A indicates a hermetically sealed glass tube of a well known form which forms a container for a bath or body of fluid B, which may be of toluol or other suitable material useful for storing and preserving suture C, which is of catgut or other material from which such sutures are commonly made. If the suture is of cat-gut, it is preferably, though not necessarily treated by impregnating or saturating with a bath of suitable antiseptic,

such as potassium mercuric iodid, or the like. Prior to its insertion in the glass tube A, at the time the storing or preserving fluid and the suture are placed in the tube, I also insert in such tube a small fusible body shown at D. This fusible body, which is preferably in the nature of a small cylinder,

as shown in Fig. 2, may be made by cutting asection or piece from a continuous wire composed of fusible material, preferably a metallic alloy. This fusible piece or body D, which is intended to fuse or melt at a predetermined degree of temperature, say about 250 Fahrenheit, is preferably made up of a suitable fusible metallic alloy, composed for instance of of 1% of silver, of bismuth and 59{%% of lead, although it will of course be understood that the materials of the alloy or relative proportions thereof may be altered to suit the individual requirements. After the suture, the storing fluid and the fusible body have all been placed in the glass tube, as shown in Fig. 1, the latter is hermetically sealed by the fusion of the glass and is then heated at a predetermined temperature, for the purpose of thoroughly sterilizing the suture. For such sterilization I prefer to employ heat at a temperature considerably in excess of the most rigid bacteriological requirements. If, for instance, I employ heat at a temperature of 275 Fahrenheit for -the purpose of sterilizing the suture, I

may if desired, make the fusible body D of such a composition or alloy that it will melt at this degree of temperature, or if desired, it may be made of an alloy which will melt at a temperature slightly below 275 Fahrenheit, says for instance, 250 F. By having the fusible alloy melt at the suture sterilizing temperature, in the example given, 275 Fahrenhelt, it will be noted that when the temperature within the tube reaches.

such point, and the alloy melts, it will indicate not only that the outside of the tubes have been subjected to the sterilizing degree of temperature specified, but that the heat has actually been conducted to the interior of the tube, thus without a doubt rendering sterile the contained suture.

"Where I have spoken of subjecting the package to heat at 275 F. for the purpose of sterilization, I have merely given this by way of example, for any desired degree of heat proper for the occasion may be employed. For instance, heat at a temperature of more than 250 Fahrenheit is usually more than ample for killing any bacterial organisms, but as stated,=I prefer to employ the heat at a temperature in excess of the most rigid bacteriological requirements.

After the package has been thoroughly sterilized through subjection to the action of heat, as above mentioned, an examination of the package will show that the fuse which was placed in the tube in the form of a short cylindrical section or piece of metal or piece of wire, is melted together in a shapeless mass or slug, as shown in Figs. 3 and 4, this melting of course having taken place when the temperature in the glass tube was raised to the predetermined degree in the example given.

In Figs. 5, 6 and 7 I have shown a modified form of fusible device which may be employed in the container in place of the fusible body D. In the modification I employ a short shank or rod E, of a fusible body or alloy, and form heads e at each end thereof. These heads are adapted to engage withthe slotted ends f of the resilient flat metallic stop F, which is preferably of spring steel, the shank and strip when assembled appearing as shownin Fig. 7, the strip constituting a bowed spring held .under tension. Now when a container having this assembled fusible device therein is heated to the proper sterilizing temperature, the melting or fusing of the shank E will permit the expansion of the bowed spring so that the latter under the action of its tension will straighten or fly out pulling the now fusing shank in half, or dividing it as will be readily understood. The whole device will thus have a dismantled appearance in the tube, clearly showing that sterilization of the contents has taken place.

In Fig. 8, I have shown another modified form of fusible device, in this instance a small spring wire member G being employed, said member being coiled interme diate its ends as at g the terminals 9 of the member being connected together by a small fusible piece or block 9 This device is also seated inthe tube and in operation when the fusible block 9 softens or melts under the influence of the sterilizing heat the two In Fig. 9, I have shown still a further modification of the invention, and one which operates on the same principle as that shown in Fig. 8, but in this case a piece of fiat spring steel or the like is bent into loop form to constitute the member H, the. ends of which are joined by the piece or block of fusible metal 72..

By making the passage so as to include the fusible body as herein described, and by. using such fusible body as an indicator for showing the sterilization or non-sterilization of the package, I eliminate .a positive source of danger incident to the use of surgical packagesof this kind. I further wish to direct attention to an important feature of my invention. It will be noted that the fusible plug forms a content or part ofthe package itself, and that it therefore constitutes a perpetual reminder or visual indicator of the condition of the specific package in that it is ever present as a part of such package itself until the glass is broken when the suture is to be used. Thus, no matter through how many hands the package may pass, such as from the laboratory of the manufacturer to the surgical supply dealer and finally tothe surgeon, the fused body confined within the sealed tube Will always remain as a positive andvisible indication,that the contained suture has beenproperly sterilized. On the other hand, in

instances where the package is sterilized in the laboratory and the fact indicated by a pyrometer or otherheat measuring device placed, during sterilization, within the ster ilizing apparatus along with the tubes of sutures, but not inside of the latter, the only person who is aware that a particular package has been sterilized is the operator who examined the pyrometer directly after the sterilization Was completed, and as such pyrometer or other heat measuring device forms no part of the package itself, there is no way by which it can be positively determined whether or not the package has been sterilized, once such package has been sent from the laboratory and into the ordinary channels of trade. With my invention, however, the condition'of thepackage with respect to its sterilization may be determined at a glance.

While I have herein shown and described the preferred embodiment of my invention, I wish it to be understood that I do not limit myself to all the details herein set forth, as modification and variation may be made without departing from the spirit of the in vention or exceeding the scope of the appended claims.

What I claim is:

1. A package comprising a sealed container having anarticle to be sterilized inclosed therein and a fusible substance car- 2, A surgical package comprising a sealed container having a fusible alloy and an article to be sterilized, both inclosed within the container. 1

3. A surgical package comprising a sealed container having therein an article to be sterilized, a storing fluid and a fusible body all inclosed therein, said fusible body melting at a predetermined temperature to indicate that the article has been subjected to a predetermined degree of heat for sterilizing purposes.

4.. A surgical package comprising a sealed glass tube having a suture, a storing fluid and a" fusible body all sealed therein, said fusible body melting at a temperature below the predetermined heat sterilizing temperature for the suture.

5. A surgical package comprising a sealed glass tube having a storing fluid and an article to be sterilized inclosed therein, and a body of'fusible'alloy also inclosed and sealed within. the glass tube, said fusible alloy beingadapted to melt at a temperature below the predetermined heat sterilizing temperature for the article. q

6. A surgical package comprising a sealed glass tube having a storing fluid and an artimetal'being adapted to melt at a predetermined temperature. I

7. A surgical package comprising a sealed glass tube having inclosed therein a storing fluid and a-suture to be sterilized, and a fusible metallic alloy also inclosed in said glass tube and adapted to melt when the tube and its contents are subjected to the action of heat at 250 Fahrenheit and upward. 8. A surgical package comprising a sealed container having therein a substance to'be sterilized and an indicating device comprising a spring member and a body of fusible material holding the spring member under tension. 7 I,

9. The herein described method of indicating when articles inclosed in containers have been sterilized, which method consists in providing the article-inclosing container with a fusible substance, and then during .the heat sterilization of the article subjecthave been sterilized, Which method consists In testimony whereof I have hereunto set in an article inclosed in the container and my hand in the presence of two subscribing With the article a body of fusible material Witnesses.

and then during the heat sterilization of the CHARLES T. DAVIS. article, subjecting said fusible substance to Witnesses: the action of the sterilizing heat to melt the BENJAMIN F Hmscn,

fusible substances Within the container, E. C. PIEIRSON. 

